Title: Oral Glucocorticoid-Sparing Effect of Benralizumab in Severe Asthma

Nair, P, MD, PhD, et al.


What You Need to Know:

Treatment with benralizumab, a monoclonal antibody that targets interleukin-5, showed significant benefits on oral glucocorticoid use as well as rates of exacerbation compared to placebo.

Trial Design:

  • Randomized, controlled, 28-week trial evaluated the efficacy of benralizumab in reducing an oral glucocorticoid dose while maintaining asthma control in patients with severe asthma
  • 220 patients were randomized to placebo or subcutaneous administration of benralizumab 30mg every 4 or 8 weeks
  • Primary endpoint: percent change in oral glucocorticoid dose
  • Secondary endpoints: percent of patients with a reduction in the mean daily oral glucocorticoid dose of ≥25%, ≥50%, or ≥100%; percent of patients with asthma control maintained with a mean daily oral glucocorticoid dose of ≥5mg

Key Outcomes:

  • 75% reduction in the median oral glucocorticoid dose in benralizumab patients vs 25% reduction in placebo patients (P<0.001)
  • Chance of reduction of oral glucocorticoid dose was 4 times higher in benralizumab group vs placebo
  • 55% and 70% lower annual exacerbation rates in patients receiving benralizumab every 4 weeks and 8 weeks, respectively, compared to placebo (marginal rate 0.54 vs 1.83; P<0.001)
  • Treatment with benralizumab showed mixed effects on asthma symptoms
  • Adverse events were similar among all groups